Comparison of the Efficacy of I-Prf Impregnated Collagen and L-Prf on Healing After Impacted Third Molar Surgery

Comparison of I-Prf Impregnated Collagen With L-Prf in Terms of Postoperative Complications and Wound Healing After Lower Impacted Third Molar Teeth Surgery

Impacted third molar extraction is a very common surgical intervention. Post-procedure pain causes various post-operative changes such as edema and trismus. Minimizing these changes will enable patients to overcome the post-operative process more easily. In this study, it was aimed to compare the possible effects of I-PRF (Impregnated Platelet Rich Fibrin) type 1 collagen with L-PRF (Leukocyte Platelet Rich Fibrin) on postoperative complications and wound healing after lower impacted wisdom tooth surgery. There are studies in the literature showing that very different treatment methods are used for buried twenty-year-old surgery. However, although there are studies in which intra-socket L-PRF, I-PRF, and collagen plugs are applied, there is no accepted standard for comparing the effects of L-PRF and I-PRF impregnated type-1 collagen with each other or for postoperative comfort. The aim of the study is to observe the effect of 2 different techniques on postoperative complications and possible changes in wound healing and discuss whether there is a difference and the effective one.

Study Overview

• Status: Active, not recruiting
• Conditions: Impacted Third Molar Tooth
• Intervention / Treatment: Procedure: I-PRF with collagen; Procedure: L-PRF

Detailed Description

Fifty patients were included for the randomized, prospective, split mouth and single-blind study. Two groups were formed in the study. The lower right and lower left wisdom teeth of the patients with extraction indication for lower impacted wisdom teeth were included in separate groups. In the first group (on one side of the same patients), leukocyte platelet-rich fibrin (L-PRF, 2700rpm,12 min) was obtained after lower impacted wisdom tooth surgery, applied into the socket and sutured. The other tooth of the patient was operated 5 weeks after the operation of the region included in the first group. In the second group (to the other side of the same patient), injectable platelet-rich fibrin (I-PRF, 700rpm, 3min) was obtained and 1*2 cm type 1 collagen plug (ACE RCP(Resorbable Collagen Plug), Resorbable Collagen Plug, Collagen Matrix, Inc. Oakland, New Jersey, USA) was impregnated and applied into the socket as such. It was followed for 4 weeks. Both surgical sites were sutured with 4\0 silk sutures (18mm, 3\8 sharp, 75cm black suture). It was determined randomly which material would be used first on which side.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Tuşba
    • Van, Tuşba, Turkey, 65080
      • Van Yuzuncu Yil University, Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Individuals aged 18 years and over,
• Patients with semi-impacted or fully impacted wisdom teeth,
• Patients without systemic disease (According to ASA(The American Society of Anesthesiologists) classification, ASA1 individuals),
• Individuals who did not use any medication in the last two weeks.

Exclusion Criteria:

• Individuals with painful temporomandibular joint disease,
• Internal irregularity and/or inflammatory joint disease with a mouth opening of less than 25 mm,
• Pregnant and lactating individuals,
• Individuals who do not come to their postoperative controls,
• Individuals using different drugs other than those recommended,
• Individuals who are allergic to the study drugs and materials.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: I-PRF + collagen; I-PRF will be applied with type 1 collagen to the extraction socket after the wisdom tooth operation.	Procedure: I-PRF with collagen; The products will be applied to the sockets after tooth extractions
Active Comparator: L-PRF; Only L-PRF will be applied to the extraction socket after the wisdom tooth operation	Procedure: L-PRF; The products will be applied to the sockets after tooth extractions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure Evaluation	Blood pressure both systolic and diastolic will measured with automatic sphygmomanometer.	Preoperative
Blood Pressure Evaluation	Blood pressure both systolic and diastolic will measured with automatic sphygmomanometer.	Right after the surgery
Pain Evaluation	Patients will requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).	Postoperative 2nd day
Pain Evaluation	Patients will requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).	Postoperative 7th day
Pain Evaluation	Patients will requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).	Postoperative 14th day
Pain Evaluation	Patients will requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).	Postoperative 28th day
Trismus Evaluation	Postoperative trismus will evaluated by the maximum distance between the incisive borders of the upper and lower right incisive teeth which was measured with a caliper.	Postoperative 2nd day
Trismus Evaluation	Postoperative trismus will evaluated by the maximum distance between the incisive borders of the upper and lower right incisive teeth which was measured with a caliper.	Postoperative 7th day
Trismus Evaluation	Postoperative trismus will evaluated by the maximum distance between the incisive borders of the upper and lower right incisive teeth which was measured with a caliper.	Postoperative 14th day
Trismus Evaluation	Postoperative trismus will evaluated by the maximum distance between the incisive borders of the upper and lower right incisive teeth which was measured with a caliper.	Postoperative 28th day
Edema Evaluation	Postoperative edema will evaluated by the distance between predetermined facial anatomic landmarks (from the mandibular angle to lateral corner of the eye, base of the nose, labial commissura, and soft tissue pogonion, tragus) which was measured with using thread and millimeter ruler.	Postoperative 2nd day
Edema Evaluation	Postoperative edema will evaluated by the distance between predetermined facial anatomic landmarks (from the mandibular angle to lateral corner of the eye, base of the nose, labial commissura, and soft tissue pogonion, tragus) which was measured with using thread and millimeter ruler.	Postoperative 7th day
Edema Evaluation	Postoperative edema will evaluated by the distance between predetermined facial anatomic landmarks (from the mandibular angle to lateral corner of the eye, base of the nose, labial commissura, and soft tissue pogonion, tragus) which was measured with using thread and millimeter ruler.	Postoperative 14th day
Edema Evaluation	Postoperative edema will evaluated by the distance between predetermined facial anatomic landmarks (from the mandibular angle to lateral corner of the eye, base of the nose, labial commissura, and soft tissue pogonion, tragus) which was measured with using thread and millimeter ruler.	Postoperative 28th day

Collaborators and Investigators

• Sponsor: Yuzuncu Yıl University
• Investigators: Study Director: Levent Ciğerim, Assoc.Prof., Van Yuzuncu Yil University, Faculty of Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2021
• Primary Completion (Estimated): November 15, 2023
• Study Completion (Estimated): December 15, 2023

Study Registration Dates

• First Submitted: February 14, 2022
• First Submitted That Met QC Criteria: September 28, 2022
• First Posted (Actual): October 3, 2022

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 20, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth, Impacted
• Other Study ID Numbers: 25.12.2020/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No